Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin

Phase 4

• Conditions: Heart Failure, Systolic
• Interventions: Drug: Sacubitril / Valsartan Oral Tablet

• Registration Number: NCT03553303
• Lead Sponsor: Oslo University Hospital

Brief Summary

The study measure multiple neurohormones in patients with heart failure being treated with Sacubitril/Valsartan in increasing doses over an 8 week period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Study Start: 2018-10-16
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-29
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients must give written informed consent before any study assessment is performed.
2. Ambulatory ≥ 18 years of age, male or female, treated at Ringerike Hospital.
3. Patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%).
4. Patients on optimized medical treatment for heart failure. -

Exclusion Criteria

1. Patients not able to comply in the study.

2. Patients having contraindication for treatment with Entresto;

   1. Hypersensitivity to the active substances or to any of the excipients listed in section
   2. Hyperkalemia: > 5.4 mmol/L
   3. Known history of angioedema related to previous ACE inhibitor or ARB therapy.
   4. Hereditary or idiopathic angioedema.
   5. Concomitant use with Aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73m2)
   6. End-stage renal disease (<15 mL/min per 1.73m2 or treatment by dialysis).
   7. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child-Pugh C classification).
   8. Pregnancy Breast-feeding-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Sacubitril / Valsartan Oral Tablet	Increasing doses of Sacubitril/Valsartan

Primary Outcome Measures

Name	Time	Method
Neurohormonal plasma concentration	8 weeks

Trial Locations

Locations (1)

Ringerike Hospital Vestre Viken Hospital Trust; 🇳🇴 Hønefoss, Buskerud, Norway